This invention relates to a nasal administration powder composition containing a physiologically active peptide as an active ingredient which has been improved in in terms of efficiency of absorption through nasal mucosa.
Peptide hormones such as insulin and calcitonin which are used as clinical drugs at present are susceptible to hydrolysis with enzymes in gastrointestinal tracts and on the wall of gastrointestinal tracts and it is very difficult to have them absorbed through gastrointestinal tracts. Thus, hitherto, they have been administered only by injections.
However, injections often cause pains and are not preferred and other administration methods have been attempted. For example, there have been proposed rectal administration as a suppository [J. Pharm. Pharmacol., 33,334 (1981)], endotracheal administration [Diabetes, 20,552 (1971)] and eyedropping administration (Summary of J. of the Diabetic Society, 237 (1974)]. However, they have not yet been put to practical use because of lower absorption rate than by injections and great variation in absorption.
Some attempts have been made on nasal administration and, for example, a method is known which uses a surface active agent as an absorption promoter [e.g., Japanese Patent Kokai Nos. 59-89619 and 59-130820 and Diabetes, 27,296 (1977)]. However, the drug is liquid and readily runs out after administration. There are further problems that safety and stability of drug are damaged due to addition of the surface active agents and incorporation of microorganisms.
On the other hand, powdered nasal administration preparations have been proposed. A powdered nasal administration preparation was already put to practical use as a preparation for Intal.RTM. (Fujisawa Pharmaceutical Co., Ltd., FISONS plc England) in 1975. Further, a powdered composition for nasal administration containing water absorbing base was proposed as the peptide preparation (Japanese Patent Kokai No. 59-163313). However, this preparation was practically not necessarily excellent since the effective component is not sufficiently absorbed from the nasal cavity.